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Recruiting

NCT Number: NCT03439228

To Brace or Not to Brace for Single Level Lumbar Fusion Pilot

The use of a lumbar brace following single-level lumbar fusion for degenerative spondylosis (non-traumatic) is variable between surgeons. Some surgeons prefer to prescribe a brace and others do not. There is a lack of guidelines and evidence to support either treatment option. The purpose of this study is to assess feasibility and collect preliminary data to conduct a larger, definitive trial to provide evidence as to whether prescribing a brace or not results in better or equal outcomes. Imaging by CT scan, one year after surgery, will be used to analyze bone fusion (healing), and functional and pain scores from patients during their recovery will be compared to identify differences between patients who wore a brace and those who did not.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location status: Recruiting

Location contact

Amanda Martyniuk, MSc

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Single-level lumbar instrumented postero-lateral fusion from L2-L5
  • Life expectancy greater than 2 years

Exclusion criteria

  • Previous lumbar surgery
  • Spine tumour/cancer
  • Documented osteoporosis
  • High grade (3 or 4) spondylolisthesis

Treatment and study plan

Lumbar brace

Device

3 months of lumbar brace wear

Primary outcomes

  1. Rate of enrolment

    Time frame: 12 months

    Feasibility measure to assess pilot project design. Assess ability to recruit 2 patients per month.

  2. Rate of study completion

    Time frame: 12 months

    Feasibility measure to assess pilot project design. Evaluate study visit and study completion rates.

Secondary outcomes

  1. Lumbar bone fusion

    Time frame: 12 months

    Status of bone fusion assessed radiologically by CT scan

  2. Functional Status

    Time frame: 3 months, 6 months, 12 months

    The Oswestry Disability Index

  3. Pain Status

    Time frame: 3 months, 6 months, 12 months

    Visual analog scale (0, no pain to 10, worst pain)

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Martyniuk, MSc

CONTACT

[email protected]

905-521-2100 ext. 44155

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Collaborators

  • DJO Incorporated
  • McMaster University
  • Stryker Canada LP

Registry information

Official study title

To Brace or Not to Brace for Single Level Lumbar Fusion: a Pilot Prospective Randomized Controlled Trial

Acronym: BRACE Pilot

Important dates

Study start
2018
Primary completion
2025
Study completion
2025
First posted
Feb 20, 2018
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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